Positive Data on Permacol
12 Luglio 2006 - 9:00AM
UK Regulatory
RNS Number:0504G
Tissue Science Laboratories PLC
12 July 2006
12 July 2006
Tissue Science Laboratories plc
("TSL" or "the Company)
Tissue Science Laboratories Presents Further Supportive Data on Permacol(R)
Studies
Positive results for Permacol(R) as a prophylactic treatment for parastomal
hernias and as a treatment for anal fistulae
At the Annual Meeting of the ACPGBI (Association of Coloproctology of Great
Britain & Ireland) held in Gateshead, 3-6 July, Tissue Science Laboratories plc,
the medical devices company specialising in human tissue replacement and repair
products, presented supportive evidence from two pilot studies - the first, an
application of Permacol(R) as a treatment for parastomal hernias and the second,
for the treatment of anal fistulae.
There are over 1.4 million existing stomas in the US and Europe, and
approximately 160,000 new stomas created per annum. Parastomal herniation (the
formation of a hernia beside the stoma) is a persistent and troublesome problem
with an approximate occurrence rate of up to 50%. The first study presented
looked at the efficacy of Permacol(R) as a prophylactic to prevent parastomal
herniation. The study comprised 20 patients - 10 treated prophylactically with
Permacol(R). 3 out of 10 patients without Permacol(R) were found to have
experienced parastomal hernias; none of the patients with the Permacol(R)
prophylactic showed herniation. Contrary to current treatments such as synthetic
mesh, there were no complications related to infection or related to the
proximity to the bowel associated with the use of Permacol(R). A full scale
randomized controlled prophylactic study is now underway.
The second pilot study aimed to assess the short-term safety, feasibility and
efficacy of using Permacol(R), either as a solid implanted seton (a thread of
material that is passed through the fistula) or as fibres suspended in fibrin
glue, to heal idiopathic anal fistulae whilst preserving continence. This has
traditionally been treated by surgery, but more recently fibrin glue is being
used with variable success. Its drawbacks include that it is broken down
relatively rapidly and it fails to eradicate secondary tracts and acute sepsis
in advance. The results of the study using Permacol(R) revealed that at three
months post-operation, no patient in either the collagen implant or collagen
glue mixture groups had experienced symptoms of continence disturbance or acute
perianal sepsis, which are usually common with this condition. Also, sphincter
integrity and anorectal movement were unchanged. The results of this study
suggest that Permacol(R) is a safe, potentially effective sphincter-conserving
technique, and the results allow an extension of the study.
Stephen Bloor, Technical Director, said: "We are pleased to report further
successful studies for Permacol(R), which has proven to offer many advantages
such as greater comfort, durability and without the many side effects of current
treatments. The results of these studies offer further supportive examples for
the multiple applications of Permacol(R)."
-Ends-
For more information please contact:
Tissue Science Laboratories Media Enquiries
plc
Martin Hunt, Chief Executive Hogarth PR
Officer
Steve Bloor, Technical Melanie Toyne-Sewell/Sarah Richardson
Director
Tel: 01252 369 603 Tel: +44 207 357 9477
Email: Email: Mtoyne-sewell@hogarthpr.co.uk
information@tissuescience.com srichardson@hogarthpr.co.uk
Website:
www.tissuescience.com
Notes to Editors
Background on TSL
Founded in 1995, with headquarters in Aldershot, Hampshire, TSL is a medical
technology company specialising in tissue repair and replacement with a
proprietary sheet product, derived from porcine dermis, called Permacol(R). TSL
has launched successfully different formulations of the product and built a
development pipeline that addresses the large and fast growing surgical implant
market. The Company floated in November 2001 and is listed on the Alternative
Investment Market (LSE: TSL).
TSL has a family of products based on the same core technology. Each product
has been adapted, with unique properties, to make it suitable for use in
different applications, including urology/gynaecology, complex and recurrent
hernia repair, shoulder rotator cuff repair and head and face repair and
reconstruction. The Company has signed distribution agreements with CR Bard Inc
(urology/gynaecology - worldwide), Zimmer Inc (orthopaedic - worldwide) and
Porex Surgical Inc (head and face - US and Canada). Further variations of the
sheet and injectable forms of Permacol(R) are being developed. For more
information on TSL, please visit the website at www.tissuescience.com.
Background on Permacol(R)
Permacol(R) was developed at Dundee and Cambridge Universities over a 20-year
time period. The key to the Permacol(R) concept lies in it collagen technology
which uses non-reconstituted porcine dermal collagen, very similar in structure
to human tissue. Non-collagenous material, except elastin, is removed by the TSL
manufacturing process. The remaining collagen, which retains its original 3-D
structural architecture, is stabilised by a patented cross-linking process. The
result is a non-reconstituted, non-allergenic, collagen implant which is
resistant to biodegradation, is recognised and accepted by the body, and is able
to provide a long-term support for the in-growth of new tissue and its
associated blood supply.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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